Posts Tagged ‘misoprostol’

Translating promise into reality: Misoprostol for post-partum hemorrhage

Monday, December 19th, 2011 by Christopher Lindahl

Written by: Ann Starrs, President, Family Care International

 

The following originally appeared on the Family Care International blog. It is reposted here with permission.

 

Every five minutes, somewhere in the developing world, a woman who has just given birth bleeds to death. Almost all of these cases of postpartum hemorrhage (PPH) can be prevented or effectively treated if every woman has access to essential health services and medicines, and particularly to uterotonic drugs.

 

Misoprostol is one such drug. Research has shown it to be safe and effective for stopping postpartum bleeding, the leading cause of death in childbirth. Misoprostol offers several unique advantages, particularly for use in low-level health facilities and in community and home birth settings: it Misoprostol tabletsdoesn’t require refrigeration, is simple to administer, is inexpensive, and is widely available. But many women still do not have access to this critical medicine – even though misoprostol is on the World Health Organization’s Model List of Essential Medicines for the prevention of PPH, is on the national essential drug lists in many countries, and is included in many global and national clinical practice guidelines.

 

In “Misoprostol for postpartum hemorrhage: Moving from evidence to practice,” a commentary we co-authored for the January 2012 issue of the International Journal of Gynecology & Obstetrics (IJGO), Beverly Winikoff (president of Gynuity Health Projects) and I note the “growing consensus that misoprostol is a safe and effective option for preventing and treating PPH, particularly in settings where oxytocin — the gold standard drug — is not available or where its administration is not feasible.” This article grew out of a multi-year collaboration between Gynuity and FCI to evaluate misoprostol and to promote wider understanding, use, and acceptance of misoprostol for preventing and treating PPH. In it, we outline the unique challenges to expanding women’s access to and use of misoprostol, including:

  • Misoprostol’s use for a range of indications, which has resulted in controversy about its possible “misuse.” Misoprostol can be used to induce abortion early in pregnancy, and can cause complications if used incorrectly before or after delivery, which has made some governments, donors, and health care professional reluctant to promote it even for appropriate uses.
  • Evidence-based guidelines and clinical protocols that, in many countries, do not reflect the latest research, and a lack of provider training in its proper use.
  • Misconceptions and misperceptions held by policy makers and health practitioners, including a fear — unsupported by the evidence — that promoting misoprostol’s use in home births could deter women from giving birth at health facilities.

There is no panacea for reducing maternal mortality: as we point out in the article’s conclusion, “no drug can replace the need for strengthened basic and emergency obstetric care services; for more and better-trained health workers; for clean, well-equipped facilities; and for culturally-sensitive, high-quality maternal health care.” But misoprostol is an essential tool, one that can help us to deliver on the world’s promise to improve maternal health. To make progress in ensuring that every woman has access to a uterotonic to prevent or treat PPH, the medical and health policy communities must work together to translate research findings on misoprostol into changes in policy, knowledge, and clinical practice.

 

Read the full article here.

 

Learn more about FCI’s work on misoprostol and PPH here.

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USAID Technical Series: Prevention and Management of PPH and PE/E

Wednesday, August 3rd, 2011 by Christopher Lindahl

Yesterday afternoon, a group of maternal health practitioners met at the Ronald Reagan Building in Washington, DC. Dr. Jeffrey M. Smith of MCHIP gave a presentation on a report he co-authored called “Prevention and Management of Postpartum Hemorrhage and Pre-Eclampsia/Eclampsia” (PDF) as part of the USAID Maternal Health Technical Series.

 

The paper reports on various themes and topics such as the active management of the third stage of labor, education and training, misoprostol, and magnesium sulfate. Dr. Smith and his colleagues collected survey responses from groups in 31 countries on their maternal health policies, implementation and management.

 

They developed some binary metrics (Yes/No) to determine how far along a given country is in their maternal health efforts to provide a global snapshot. Then, the answers were represented in graphs to allow readers to see where gaps may exist. For example, their research found that all 31 countries surveyed had national policies in place for the use of magnesium sulfate use for preeclampsia/eclampsia, however, in only 48% of countries was magnesium sulfate regularly available in facilities. Dr. Smith argues that this indicates that we do not necessarily need to worry about national policy but drug availability.

 

Finally, the conversation turned towards the need for better data and more detail on maternal health. Most of our metrics, number of antenatal care visits or percentage of births attended by a skilled professional, are based simply on contact with the health system, but do not reveal anything about the content or quality of those visits. Dr. Smith also lamented the fact that we only have regional data for causes of maternal death, while for child mortality, country level data is available.

 

The report then lays about concept maps to show the progress being made (or lack thereof) in the 31 surveyed countries. Each indicates where programming is completed, exists, or does not exist on topics relating to PPH and PE/E.

 

The report concludes:

Findings from this survey indicate a disparity between nationally approved policies and education guidelines to reduce PPH and PE/E and actual services delivered. Multiple, creative approaches are needed—and are being implemented—to address this gap between policy and practice. Possible approaches include quality improvement initiatives, change management strategies and mHealth approaches…More emphasis must be placed on training and supervision to increase utilization of high impact interventions, specifically use of AMTSL and MgSO4. This analysis also demonstrated the need to consider and address indirect utilization barriers for these high-impact interventions.

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Misoprostol for postpartum hemorrhage: from evidence to action

Monday, August 1st, 2011 by Christopher Lindahl

Written by: Shafia Rashid, Senior Program Officer, FCI Global Advocacy program.

 

The following was originally posted on FCI’s blog. It is reposted here with permission.

 

Around the corner from the New York Stock Exchange, where financial decisions of global importance are made every day, more than 50 obstetricians, midwives, women’s rights advocates, public health programmers, researchers, and policy makers from around the world gathered last week for discussions on a different, but equally momentous, subject. FCI, working in collaboration with Gynuity Health Projects, brought together this diverse group for a two-day meeting to help shape policy and advocacy on the use of the drug misoprostol for the prevention and treatment of postpartum hemorrhage (PPH). In the developing world, uncontrolled post-partum bleeding is the leading cause of death in childbirth, killing a woman every five minutes.

 

In studies conducted by Gynuity and others, misoprostol has been shown to be a safe and effective medicine both for the prevention and for the treatment of PPH. While another drug, oxytocin, is generally recognized as the “gold standard” among uterotonic drugs for preventing or treating PPH, misoprostol has significant advantages for use in settings where maternal mortality is high and most births take place outside of hospitals: misoprostol is delivered in tablet form, and — unlike oxytocin — requires neither refrigeration nor intravenous administration. Earlier this year, misoprostol was added to the World Health Organization’s Model List of Essential Medicines for the prevention of PPH, providing another opportunity to expand women’s access to this safe and inexpensive medicine. Misoprostol, originally developed for treatment of stomach ulcers, is also used for a range of reproductive health indications, including induction and augmentation of labor and medical abortion.

 

The New York meeting aimed to translate the scientific evidence on misoprostol’s safety and efficacy into effective strategies for expanding women’s access to misoprostol at the country level. After reviewing the scientific research, the global clinical and policy guidelines that shape the use and availability of misoprostol, and the strategies being used by misoprostol advocates and programmers, participants discussed opportunities, barriers, and challenges related to promoting greater access to misoprostol for PPH. Human rights experts framed how access to misoprostol is a human right enshrined in several international frameworks, including the Universal Declaration of Human Rights. Presentations and discussions highlighted the need not only to drive policy change at the country level (e.g., getting misoprostol registered for this indication, including it on national essential drug lists, and incorporating it within national clinical norms and guidelines), but also to ensure that these policies are adequately implemented and funded so that they translate into real progress for women.

 

Presenters from Nepal, Kenya, and Ecuador shared lessons from successful efforts to achieve policy approval and expand distribution of misoprostol, and participants from countries including India, Tanzania, Uganda, Burkina Faso, and Laos also contributed their experiences. These discussions included promising results from several countries where distribution of misoprostol tablets to women in their communities has proven effective in addressing the risk of hemorrhage among women who give birth at home — where more than half of births in the developing world still take place — with extremely low levels of diversion of the drug for other uses, incorrect dosage or timing of administration, or other signs of poor compliance. Attendees also learned about advocacy campaigns in related sectors, including emergency contraception, medical abortion, and the HPV vaccine for cervical cancer, and considered how those lessons may be applied to improving access to misoprostol for PPH.

 

Looking ahead, FCI will work with our partners to develop and implement an advocacy and communications strategy that will drive real progress in helping countries, health care providers, and women themselves address the leading cause of maternal death. Please stay tuned to The FCI Blog for more information as this exciting and important project moves forward.

 

To read FCI’s mapping report on advocacy for access to misoprostol, click here: Mapping_Miso_For_PPH.

 

To read about FCI’s work on misoprostol for PPH, click here.

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WHO approves misoprostol to prevent hemorrhage

Monday, May 23rd, 2011 by Christopher Lindahl

Written by: Shafia Rashid, Senior Program Officer, Global Advocacy, FCI

 

The following was originally published on the FCI blog. It is reposted here with permission

 

Last week, the WHO Expert Committee on the Selection and Use of Essential Medicines approved the inclusion of misoprostol for the prevention of postpartum hemorrhage (PPH) on the WHO List of Essential Medicines. PPH,or severe bleeding following childbirth, is one of the major causes of maternal death and disability in developing countries. The Expert Committee noted that “600 micrograms [misoprostol] given orally is effective and safe for the prevention of PPH” in settings where oxytocin, currently the standard of care to prevent PPH, is not available or feasible. Moreover, the committee moved misoprostol from the complementary to the core list of essential medicines, validating the drug’s important role in women’s health.

 

Structure of the misoprostol molecule/www.3dchem.com

Structure of the misoprostol molecule

Misoprostol, a prostaglandin, offers several potential advantages over oxytocin for managing PPH in resource-constrained settings. It is widely available in developing countries, is relatively inexpensive, can be transported and stored without refrigeration, and can be administered without an injection.

 

The addition of misoprostol to the WHO List of Essential Medicines is an important step forward in making the drug more widely available for PPH, and provides a critical opportunity for disseminating clear, evidence-based information to ministries of health, regulatory authorities, health system managers, health workers, and other audiences.

 

Strong, effective, and consistent advocacy at the global, regional, and country levels is critical for improving women’s access to misoprostol for both prevention and treatment of PPH. FCI is working with Gynuity Health Projects and other partners to develop an evidence-based advocacy agenda and communications plan to harmonize and disseminate messages on the use of misoprostol for preventing and managing PPH.

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Decision on Addition of Misoprostol to WHO EML for Treatment & Prevention of Postpartum Hemorrhage

Monday, May 23rd, 2011 by Christopher Lindahl

May 19, 2011

 

Dear Colleagues:

 

It has been several months since you lent your support to add misoprostol for prevention and treatment of post-partum hemorrhage (PPH) to the World Health Organization’s (WHO) Model List of Essential Medicines. The 18th Expert Committee on the Selection and Use of Essential Medicines met in Accra, Ghana in March 2011 to review the applications for misoprostol to be added to the WHO’s essential medicines list (EML) for the prevention and treatment of PPH. There was a huge outpouring of support for the inclusion of misoprostol for both indications by international policy-making and programmatic agencies and outside expert reviewers that positively reviewed both applications.

 

On May 6th, the Expert Committee published its results which “add misoprostol to the [Essential Medicines] List, for the prevention of PPH in settings where parenteral uterotonics are not available or feasible.” Additionally the committee moved the drug from the complementary to the core list of essential medicines. The committee’s report cited a recently completed study from Pakistan, demonstrating that “there may be a benefit from use of misoprostol by traditional birth attendants or assistants trained on the use of the product at home deliveries. Unfortunately, the committee did not approve the inclusion of misoprostol for its specific PPH treatment indication at this time. The unedited draft report is available on the WHO website at: http://www.who.int/medicines/publications/unedited_trs/en/index.html.

 

Regarding misoprostol for PPH treatment, the committee expressed some concerns which led to their decision to withhold approval at this time. The major stumbling blocks noted by the committee appear to be concerns about the very limited (e.g. no) data to support the use of misoprostol for treatment of PPH among women who have previously received prophylactic misoprostol to prevent PPH as well as about possible side effects after 800 micrograms (mcg) of sublingual misoprostol. . The committee also indicated a worry that any recommendation to use misoprostol for both PPH prevention and treatment could reduce attempts to make oxytocin more available. It is important to underscore however, that the committee also noted in its report that WHO guidelines and other internationalguidelines recommend misoprostol for both the prevention and treatment of PPH due to atony, where parenteral uterotonics are not available.

 

We are pleased that the EML will now include the 200-mcg tablet of misoprostol for its PPH prevention indication, in addition to:

  1. a 25‐mcg vaginal tablet, for use in induction of labor;
  2. a 200‐mcg tablet to be used in combination with mifepristone, for termination of pregnancy (where legally permitted and culturally acceptable);
  3. a 200‐mcg tablet for the management of incomplete abortion and miscarriage.

Moreover, the addition of misoprostol to the Core List is a strong validation of the drug’s role in women’s health. Future research will address misoprostol use for PPH treatment after its use for PPH prevention. Such use of the drug is certainly already a reality in places where oxytocin is not yet available and/or feasible to use. These results and other supportive data will be submitted to the Expert Committee on the Selection and Use of Essential Medicines again for consideration in two years.

 

Many organizations, including Gynuity Health Projects and Venture Strategies Innovations, continue to support the addition of misoprostol to the Model List of Essential Medicines for its specific post-partum hemorrhage treatment indication and will continue to advocate for its inclusion in the future.

 

We thank you again for your support of this issue.

 

Sincerely,

 

Jennifer Blum, M.P.H., Gynuity Health Projects
Ndola Prata, M.D., M.Sc., Venture Strategies Innovations, Associate Professor in Residence, University of California, Berkeley
Kirsten Moore, Reproductive Health Technologies Project

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Misoprostol added to WHO list of essential medicines for PPH

Thursday, May 19th, 2011 by Christopher Lindahl

Postpartum hemorrhage (PPH) is the leading cause of maternal mortality, accounting for about 25% of all maternal deaths. Misprostol is an easy to use drug that is shown to be successful in preventing PPH. Earlier this month, the World Health Organization added misoprostol to its List of Essential Medicines for the prevention of PPH. The news is the culmination of years of research and advocacy.

 

Jill Sheffield of Women Deliver writes:

Now that misoprostol is recognized as an essential medicine, we must take the next step and help translate this development into increased awareness, approval, and access in every country with a high rate of maternal death. The small white pill is inexpensive, stable even in warmer climates, and is easy-to-use, making it ideal for community-level delivery where oxytocin is not available or cannot be safely used. Simply put, this pill can save lives by preventing women from bleeding to death during and after delivery.

 

Krishna Jafa of PSI also lauds the decision:

The WHO’s designation of misoprostol in its List of Essential Medicines is significant because many national governments follow WHO guidelines when drawing up their own national essential medicines list; drugs on national essential medicines lists are often prioritized by governments for budgetary allocations and procurement. We can now expect that misoprostol will be more widely available in the places it is most needed.

 

Finally, Melanie Holden of Venture Strategies Innovations says:

Within VSI we are elated. This is a tremendous boon for women’s health and solidifies misoprostol’s role in making childbirth safer. As co-authors of the application with Gynuity Health Projects, we are enormously proud of this accomplishment and how it will translate to lives saved around the globe.

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Weekend Reading

Friday, April 22nd, 2011 by Christopher Lindahl

This week on the MHTF blog:

  1. We posted about an upcoming USAID Maternal Health Technical Series
  2. We commented on the World Bank-IMF Global Monitoring Report
  3. There was a Maternal Health Policy Dialogue on accessing care in urban slums
  4. Mama was launched by the Women’s Refugee Commission and Marketing for International Development
  5. Today is the deadline to apply for the Women Bloggers Deliver

Some reading for the weekend:

  1. Scaling up post abortion care
  2. A scorecard for identifying risk in Mumbai
  3. Misoprostol trials showing results in Senegal
  4. The impact of performance-based payment for health providers in Rwanda
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Misoprostol and PPH on GlobalMama

Thursday, March 24th, 2011 by Christopher Lindahl

We have a new post up today on our Medscape blog GlobalMama on new Bangladesh MMR numbers, misoprostol and PPH. In order to view the post, you must register for a free account on Medscape.

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Misoprostol in Pakistan event at USAID

Monday, January 10th, 2011 by Christopher Lindahl

Trained traditional birth attendants in Pakistan provide misoprostol to prevent postpartum haemorrhage: a randomised placebo-controlled trial

 

Jill Durocher, Program Associate, Gynuity Health Projects
Jennifer Blum, Senior Program Associate, Gynuity Health Projects

 

Monday, January 24, 2011
2:00-3:00 PM
Ronald Reagan Building
1300 Pennsylvania Avenue, NW
Washington, D.C. 20523
Room: 4.8 E/F

 

About the event: Postpartum haemorrhage (PPH) continues to be the leading single direct cause of maternal mortality worldwide. Despite global efforts to ensure that women deliver with skilled birth attendants and have access to conventional uterotonics for PPH prevention, 60% of births in low resource countries occur outside health facilities without a skilled attendant. In Pakistan, 65% of births occur at home and 27% of maternal deaths are attributed to PPH. Today’s talk summarizes results from a randomized controlled trial testing the impact of post-partum administration of 600 mcg oral misoprostol on PPH by Pakistani trained traditional birth attendants. The data show a 24% reduction in PPH among women given misoprostol after delivery. These results, in conjunction with other published reports on misoprostol for PPH prevention, support the drug’s effectiveness in preventing PPH in places where oxytocin is either not available or not feasible. We also hope that these results will bolster WHO support to list misoprostol for its specific PPH prevention indication on its Essential Medicines List.

 

Jill Durocher will share results from this newly published trial and discuss its implication for programs introducing misoprostol for PPH prevention. Jennifer Blum will be on hand to discuss how this relates to Gynuity’s current portfolio of work on misoprostol for the prevention and treatment of PPH globally.

 

Please join USAID and Gynuity Health Projects for this presentation—newly published in BJOG. All are invited. Please contact Tierra Smith (tsmith@usaid.gov) for pre-clearance into the building.

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The Five Steps to Achieving MDG 5 and Saving Mothers’ Lives

Wednesday, September 22nd, 2010 by Raji Mohanam

This is a cross-posting. The post was first published on the The Huffington Post

Written By: Pam Barnes, President, EngenderHealth

This week, the world’s leaders will descend on New York City for a perfect storm of high-level events, including the United Nations Summit on the Millennium Development Goals. Millennium Development Goal No. 5 (MDG 5)—improve maternal health—will be top of mind. UN Secretary General Ban Ki-moon is expected to launch a Global Strategy for Women and Children’s Health. And the Clinton Global Initiative Annual Meeting is dedicating an entire track to women’s and girls’ empowerment. Just this week, the UN released its latest maternal health estimates, reaffirming that, while there is evidence of progress, clearly there is much more work to be done. The good news is that the momentum behind this issue has never been greater.

Earlier this month, I had the privilege of attending the Global Maternal Health Conference 2010 in Delhi, India, with nearly 700 of the world’s foremost experts in the field. The conference was a forecast of the topics and solutions that are likely to dominate discussions on MDG 5 this week. Here are the top five:

1. Solutions are only solutions if they land in the right hands. Severe bleeding after childbirth, infections, hypertensive disorders, and unsafe abortions are the primary causes of maternal death. Safe, effective, and low-cost preventive measures and treatments exist; the challenge has been making sure that these medical technologies reach women, especially poor women, as quickly as possible. Health professionals are experimenting with new ways to effectively distribute lifesaving drugs. For example, a central strategy for expanding access to misoprostol to prevent postpartum hemorrhage involves using trained community volunteers to distribute the drug. This allows women, a majority of whom continue to give birth at home and may be far from the nearest health facility, to safely treat themselves at home postpartum.

2. Find creative solutions to increase the number of skilled health providers. The shortage of health professionals is a major barrier to reducing maternal mortality and morbidity. One approach has been to “task shift”—train and deploy more nonphysician clinicians to take on a broader range of health services, including some emergency obstetric care. Studies of this practice have shown that, given the right training and support, these providers are up to the task, having success equal to that of doctors. But this strategy is a longer term prospect and should not detract from the equally important goal of training more skilled doctors, nor should task shifting result in any health provider becoming burdened with too many responsibilities.

3. Hold decision makers accountable. Government leaders worldwide have formally committed to achieving the MDGs, but accountability has been a problem. On this front, what happens outside the health clinic can be as important as what happens within it. Just as we need more people trained to provide maternal health services, we must also invest in training advocates to pressure ministers of health and other decision makers to make real investments in reproductive health care. In many countries, a key aspect of this work involves compelling governments to provide data on where money earmarked for maternal health is spent. The Ask Your Government campaign is doing innovative work on this front to learn the extent to which governments are actually deploying the resources needed to achieve the MDGs.

4. Connect the dots. Health providers are getting increasingly sophisticated about drawing links between the underlying cultural, social, and economic factors that contribute to maternal deaths. An expectant mother who is HIV-positive, for example, needs special attention to protect her health and to help her deliver a healthy baby. Maternal health is not a “vertical issue,” but one that cuts across all of the Millennium Development Goals.

5. Strike the right balance between community- and facility-based care. For years, there has been debate about whether women are better served in health facilities or through community-based services. Such services may lack highly skilled doctors, but they also are often more accessible to poor women in rural areas. Experts at the Global Maternal Health Conference agreed that the time had come to reframe the discussion from “either or” to “both.” Where facilities are inadequate, community-based interventions can potentially serve women’s needs. But where facilities are adequate, community-based services still can be critical for supporting prenatal and postnatal care. The bottom line: Local context is everything. We need to use the approaches that best meet the realities of women in any given community.

MDG 5 consists of two specific targets. The first calls for a 75 percent reduction in maternal mortality between 1990 and 2015. This is the part that most people remember. The second part doesn’t get as much attention: the goal of universal access to reproductive health care. Yet, as the five steps above demonstrate, the two parts are inextricably linked. If the initial launch of the Global Millennium Development Goals more than 10 years ago was to answer the what and why behind eradicating poverty and improving global health, then the focus now must be how we will do so.

Check out MDGFive.com, a new media initiative uniting global artists and activists for maternal health.

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